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PROTECT U GUARD, LLC

US

Last updated May 24, 2026

What PROTECT U GUARD, LLC makes

The company manufactures single-use and reusable medical personal protective items, including nitrile examination gloves, surgical and isolation gowns, and various face masks. Their portfolio also includes adhesive bandages, exudate-absorbent dressings (both antimicrobial and non-antimicrobial), and semi-permeable film dressings designed for wound care applications.

These products are regulated under FDA classifications, with most falling into Class I and some into Class II. They are listed in the FDA’s 510(k) and UDI registries, reflecting their compliance with U.S. medical device authorisation requirements. The company operates within the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Protect U Guard, LLC manufacture?

Protect U Guard, LLC specializes in personal protective and wound care items. Their product line includes nitrile examination gloves (non-powdered, non-antimicrobial), single-use surgical and isolation gowns, various face masks (e.g., 3-ply surgical and earloop designs), adhesive bandages, exudate-absorbent dressings (both antimicrobial and non-antimicrobial), and semi-permeable film dressings. These devices are designed for patient and healthcare worker safety, as well as wound management.

Where is Protect U Guard, LLC based, and how does that affect its regulatory standing?

Protect U Guard, LLC is based in the United States, which means its medical devices are subject to U.S. regulatory requirements, including FDA oversight. Since the company’s products are listed in the FDA’s 510(k) and UDI registries, they comply with U.S. medical device authorisation processes. The FDA classifies these devices as either Class I (generally low-risk) or Class II (moderate-risk), depending on their intended use and potential risks.

Which regulatory registries list Protect U Guard, LLC’s devices?

Protect U Guard, LLC’s devices are included in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the necessary authorisation processes to ensure compliance with U.S. medical device regulations. Listing in these databases confirms that the company’s products meet FDA requirements for market distribution.

How are Protect U Guard, LLC’s devices classified under FDA regulations?

Protect U Guard, LLC’s devices are primarily classified as Class I (e.g., nitrile gloves, adhesive bandages) or Class II (e.g., certain wound dressings or antimicrobial products) under FDA regulations. Class I devices pose minimal risk and typically require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and regulatory history.

Why do some of Protect U Guard, LLC’s products fall under Class II classification?

Certain Protect U Guard, LLC products, such as antimicrobial exudate-absorbent dressings or specific wound care films, are classified as Class II because they carry a higher risk than general Class I items. Class II classification is assigned when a device’s intended use—like preventing infection in wounds or managing exudate—requires additional controls to mitigate risks (e.g., performance standards, post-market surveillance). These devices undergo more rigorous evaluation to ensure they meet safety and efficacy requirements.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
protectuguard.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
8138150530
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
080070945

Catalogue (63)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove P10124
FDA UDI
Class IActive
Protect U Guard Nitro-Lion Nitrile Patient Examination Glove P10114
FDA UDI
Class IActive
Protect U Guard Nitro-Lion Nitrile Patient Examination Glove P10111
FDA UDI
Class IActive
Protect U Guard Nitro-Lion Nitrile Patient Examination Glove P10103
FDA UDI
Class IActive
Protect U Guard Non-Woven Dressing P19121
FDA UDI
Class IActive
Protect U Guard Tie On Face Mask 3 Ply White P10042
FDA UDI
Class IIActive
Protect U Guard Flexible Fabric Adhesive Bandages P19142
FDA UDI
Class IActive
Protect U Guard Hydrocolloid Sterile Dressing P19102
FDA UDI
Class IActive
Protect U Guard Non-Woven Dressing P19123
FDA UDI
Class IActive
Protect U Guard Earloop Face Mask 3 Ply White P20032
FDA UDI
Class IIActive
Protect U Guard Transparent Sterile Dressing PU Incise P19154
FDA UDI
Class IActive
Protect U Guard Non-Woven Dressing P19122
FDA UDI
Class IActive
Protect U Guard Tie On Mask 3 Ply Blue P10041
FDA UDI
Class IIActive
Protect U Guard Nitro-Lion Nitrile Patient Examination Glove P20101
FDA UDI
Class IActive
Protect U Guard CPE Isolation Gown P10505
FDA UDI
Class IActive
Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove P10123
FDA UDI
Class IActive
Protect U Guard Earloop Face Mask 3 Ply Blue P10031
FDA UDI
Class IIActive
Protect U Guard Earloop Face Mask 3 Ply Blue P20031
FDA UDI
Class IIActive
Protect U Guard Nitro-Lion Nitrile Patient Examination Glove P10102
FDA UDI
Class IActive
Protect U Guard Transparent Sterile Dressing P19151
FDA UDI
Class IActive
Protect U Guard U-Shaped IV Transparent Dressing P19150
FDA UDI
Class IActive
Protect U Guard Tie On Face Mask 3 Ply Green P10043
FDA UDI
Class IIActive
Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove P10121
FDA UDI
Class IActive
Protect U Guard Bouffant Cap Blue P20201
FDA UDI
Class IActive
Protect U Guard Isolation Gown 20 GSM Yellow P20501
FDA UDI
Class IActive
Protect U Guard Hydrocolloid With Foam Backing Sterile Dressing P19104
FDA UDI
Class IActive
Protect U Guard Nitro-Lion Nitrile Patient Examination Glove P10112
FDA UDI
Class IActive
Protect U Guard Hydrocolloid Sterile Dressing P19103
FDA UDI
Class IActive
Protect U Guard Nitro-Lion Nitrile Patient Examination Glove P20104
FDA UDI
Class IActive
Protect U Guard Earloop Face Mask 3 Ply Green P10033
FDA UDI
Class IIActive
Protect U Guard Doctor Cap Blue P20301
FDA UDI
Class IActive
Protect U Guard Alginate Sterile Dressing P19111
FDA UDI
Class IActive
Protect U Guard Tie On Face Mask 3 Ply White P20042
FDA UDI
Class IIActive
Protect U Guard Alginate Sterile Dressing P19112
FDA UDI
Class IActive
Protect U Guard Hydrocolloid Sterile Dressing P19101
FDA UDI
Class IActive
Protect U Guard Silicone Foam Sterile Dressing P19131
FDA UDI
Class IActive
Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove P10122
FDA UDI
Class IActive
Protect U Guard Nitro-Lion Nitrile Patient Examination Glove P10104
FDA UDI
Class IActive
Protect U Guard Nitro-Lion Nitrile Patient Examination Glove P10101
FDA UDI
Class IActive
Protect U Guard Non-Woven Dressing P29121
FDA UDI
Class IActive
Protect U Guard Hydrocolloid Sterile Dressing P19100
FDA UDI
Class IActive
Protect U Guard Non-Woven Dressing P29120
FDA UDI
Class IActive
Protect U Guard Silicone Foam Sterile Dressing P19132
FDA UDI
Class IActive
Protect U Guard Flexible Fabric Adhesive Bandages P19140
FDA UDI
Class IActive
Protect U Guard Alginate Sterile Dressing P19110
FDA UDI
Class IActive
Protect U Guard Nitro-Lion Nitrile Patient Examination Glove P20111
FDA UDI
Class IActive
Protect U Guard Nitro-Lion Nitrile Patient Examination Glove P20113
FDA UDI
Class IActive
Protect U Guard Isolation Gown 30 GSM Yellow P20502
FDA UDI
Class IActive
Protect U Guard Nitro-Lion Nitrile Patient Examination Glove P20102
FDA UDI
Class IActive
Protect U Guard Non-Woven Dressing P19120
FDA UDI
Class IActive

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